FDA Announces Measures to Speed Up Review of U.S ANDAs

Amid all the ongoing Tariff Turf War, the U.S. Food and Drug Administration (FDA) has announced a new pilot program to en­cour­age US drugmakers to use do­mes­tic sup­plies of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents for gener­ic drugs. The initiative aims to expedite the review of Abbreviated New Drug Applications (ANDAs) submitted by drugmakers that:

• Manufacture the finished dosage form in the U.S.
• Use US-based API sources
• Conduct bioequivalence (BE) testing in the U.S.

According to the FDA, more than half of pharmaceuticals distributed in US are manufactured abroad and only 9% of API manufacturers are in the U.S., compared to 22% in China and 44% in India. The US Administration has been focussing on strengthening domestic pharmaceutical infrastructure and accelerating establishment of high priority new pharmaceutical manufacturing facilities in the U.S

Under this pilot, eligible ANDA submissions may receive priority review as defined in FDA’s Manual of Policies and Procedures (MAPP 5240.3 – Prioritization MAPP. The guidance originally applied to applications addressing drug shortages, public health emergencies, or government procurement programs.

Applicants under the priority review may receive either a shorter goal date or an expedited review.

• A shorter goal date (typically reduced from 10 months to 8 months or less), or
• An expedited review, earlier reviewer assignment, faster facility inspections

Together, these measures can be a significant advantage to U.S. generic drug applicants by reducing regulatory timelines and avoiding delays associated with foreign site inspections.

• FDA Announcement of ANDA Prioritization Pilot for US Generics (October 2025)
• USFDA MAPP 5240.3 – Prioritization of the Review of Original ANDAs, Amendments, and Supplements